Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000825
Status:
COMPLETED
Last Update Posted:
2021-10-29
First Post:
1999-11-02
Brief Title:
The Effects of Giving Interleukin-2 IL-2 Plus Anti-HIV Therapy to HIV-Positive Patients With CD4 Cell Counts of at Least 350 Cellsmm3
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Open-Label Phase II Study of Subcutaneous Interleukin-2 Proleukin Plus Antiretroviral Therapy vs Antiretroviral Therapy Alone in Patients With HIV Infection and at Least 350 CD4 Cellsmm3
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the safety and tolerability of giving IL-2 plus anti-HIV antiretroviral therapy to HIV-positive patients with CD4 cell counts cells of the immune system that fight infection of at least 350 cellsmm3 This study will also examine the ability of antiretroviral therapy combined with IL-2 to boost the immune system
IL-2 given through injection under the skin in combination with anti-HIV therapy can increase CD4 cell counts This study examines 3 doses of IL-2 in order to determine the safest and most effective dose to use
IL-2 given through injection under the skin in combination with anti-HIV therapy can increase CD4 cell counts This study examines 3 doses of IL-2 in order to determine the safest and most effective dose to use
Detailed Description:
IL-2 administered subcutaneously in combination with antiretrovirals has resulted in increased CD4 cell counts which may retard HIV disease progression Using a smaller patient sampling this Phase II study helps develop the clinical experience needed to consider formation of a larger more complete Phase III trial
Seventy-two HIV-infected patients previously treated or naive are randomized independently to receive either control therapy with antiretrovirals alone OR escalating doses of subcutaneous interleukin-2 IL-2 plus antiretrovirals In the absence of dose-limiting toxicity DLT in at least 9 of 12 patients in Group 1 12 additional patients are entered into Group 2 and treated as indicated In the absence of DLT in 9 of 12 patients in Group 2 the final 12 patients are entered into Group 3 Those patients enrolled in either of the first 2 dose groups who complete 3 courses of therapy have their dose escalated to a maximum dose A course of treatment is defined as 5 days of IL-2 plus antiretrovirals followed by 7 weeks of antiretroviral therapy alone
Seventy-two HIV-infected patients previously treated or naive are randomized independently to receive either control therapy with antiretrovirals alone OR escalating doses of subcutaneous interleukin-2 IL-2 plus antiretrovirals In the absence of dose-limiting toxicity DLT in at least 9 of 12 patients in Group 1 12 additional patients are entered into Group 2 and treated as indicated In the absence of DLT in 9 of 12 patients in Group 2 the final 12 patients are entered into Group 3 Those patients enrolled in either of the first 2 dose groups who complete 3 courses of therapy have their dose escalated to a maximum dose A course of treatment is defined as 5 days of IL-2 plus antiretrovirals followed by 7 weeks of antiretroviral therapy alone
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 10466 | REGISTRY | None | None |
| SQIL-2 | None | None | None |
| SQIL-2 Houston | Registry Identifier | DAIDS ES | None |